Data Element
Consent for research use
Submitted By: Anthony Corso / Veeva Systems
Data Element Information
Data Element Description Captures whether an individual has authorized participation in research or approved the use or sharing of their data for research purposes. This includes documentation of consent for trial enrollment, data sharing, or real-world evidence generation.
Rationale for Separate Consideration Consent-related elements exist, but do not distinguish between treatment, data sharing, and research-specific use. Research consent carries unique regulatory and ethical obligations distinct from general care consent. It also requires distinct metadata elements like scope, expiration, and linkage to study or sponsor identifiers.
Use Case Description(s)
Use Case Description At the time of enrollment or pre-screening for a clinical trial, an individual is asked to authorize the use of their data for research. This consent status needs to be digitally recorded and made interoperable across systems. Example events include: Clinical site captures research consent using eConsent or paper systems; Sponsor or CRO systems query EHR data to confirm that consent for data sharing or trial participation is documented; Data is shared with research sponsors, registries, or real-world evidence platforms.
Estimate the breadth of applicability of the use case(s) for this data element Aligns with Level 2 – This data element applies broadly across all care settings and patient populations where clinical research or real-world evidence (RWE) generation occurs. It is relevant to: Academic medical centers and community hospitals conducting interventional and observational studies; Sites participating in decentralized trials, registries, and pragmatic trials; Providers sharing electronic health record (EHR) data for external research or analytics; and Public health and population research programs requiring consent metadata.

The use case is particularly important as the industry expands its reliance on EHR-based research, FDA real-world data submissions, and learning health systems. Capturing consent for research use at the point of care or within patient portals enables scalable, standards-based support for patient-authorized data sharing and trial matching.
Supporting Attachments Veeva_USCDI_v6_Comments.pdf
Use Case Description Decentralized and Hybrid Trials
Enabling decentralized or hybrid clinical trials by capturing and sharing a participant’s research consent status from patient-facing applications (such as mobile consent tools or site portals) back into provider EHRs and research platforms. This supports trial coordination, regulatory compliance, and data exchange in real time.
Estimate the breadth of applicability of the use case(s) for this data element Hundreds of research sponsors and contract research organizations (CROs), thousands of provider organizations and research sites, and tens of thousands of patients participating in decentralized trials would be affected. This data element would play a critical role across stakeholders involved in FDA-regulated research using real-world data.
Use Case Description Multi-Institution Research Networks
Supporting large-scale multi-institution research networks (e.g., PCORnet, CTSA hubs, NIH-funded consortia) that require interoperable research consent data to accurately include or exclude patients from cohorts. Standardized consent status exchange reduces redundant manual verification and ensures consistent interpretation of participant intent across organizations.
Estimate the breadth of applicability of the use case(s) for this data element Dozens of research networks, encompassing hundreds of hospitals and academic medical centers, and affecting millions of potential participants whose consent status must be reliably communicated and honored across systems.
ONC Priority
  • Mitigate health and health care inequities and disparities
  • Address the needs of underserved communities
  • Address public health interoperability needs of reporting, investigation, and emergency response
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) The HL7 FHIR Consent resource provides structured representation of patient consent, including for research use. This can reference SNOMED CT, LOINC, or specific policy URIs to represent the purpose of us
https://hl7.org/fhir/consent.html
Additional Specifications The FHIR US Core Implementation Guide (https://hl7.org/fhir/us/core/) and other IGs, such as FHIR ResearchStudy (https://hl7.org/fhir/researchstudy.html), incorporate consent elements in research and data sharing contexts.
Current Use (Level 2) Captured, stored, or accessed in multiple production EHRs or other HIT modules from more than one developer
Extent of exchange (Level 2) Between more than two production EHRs or other HIT modules using available interoperability standards
Supporting Artifacts HL7 FHIR® R4 Consent Resource: Supports representation of research consent directives
US Core Implementation Guide: Consent for sharing and research-related purposes included
Use in production by major EHR vendors including Epic and Cerner for research consent management
Use in NIH initiatives (e.g., All of Us Research Program) and PCORnet for EHR-integrated research workflows
Integrated in eConsent platforms for clinical trials and real-world data collection
https://www.hl7.org/fhir/consent.html
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) There are no proprietary restrictions on the standardization of this data element. HL7 FHIR Consent Resource and related profiles for research consent are publicly available and maintained by standards development organizations.
Restrictions on Use (e.g. licensing, user fees) There are no licensing or user fee restrictions associated with the use of this data element. The HL7 FHIR Consent Resource and supporting implementation guides are openly accessible under the HL7 FHIR terms of use.
Privacy and Security Concerns Because this data element captures an individual’s authorization to participate in research, it inherently contains sensitive information about consent status, conditions, and potentially the type of research. Misuse or improper access to this data could compromise patient autonomy and trust. As such, strict adherence to HIPAA, 45 CFR 46 (Common Rule), and institutional privacy policies is required. Role-based access controls, audit logging, and encryption should be enforced during storage and transmission.
Estimate of Overall Burden The overall burden to implement this data element is moderate. While most certified EHRs already support capturing consent for treatment and disclosure, extending that infrastructure to accommodate research-specific consent requires mapping consent types, managing expiration/withdrawal, and ensuring alignment with study protocols and IRB standards. However, because HL7 FHIR Consent is already widely supported in modern EHR platforms and consent workflows are common in research organizations, implementation is feasible with modest configuration and governance updates.
Other Implementation Challenges Key challenges include variation in institutional workflows for consent management, lack of harmonization across research networks, and inconsistent mapping of structured consent data to external registries or sponsors. Additionally, some organizations rely on scanned documents or PDFs rather than structured electronic consent, which can limit the ability to exchange discrete, computable data across systems.
ONC Evaluation Details
Each submitted Data Element has been evaluated based on the following criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
Criterion #1
Maturity - Current Standards		 Level 2 - Data element is represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2
Maturity - Current Use 		Level 0 - Data element is captured, stored, or accessed in limited settings such as a pilot or proof of concept demonstration.
Criterion #3
Maturity - Current Exchange		 Level 0 - Data element is electronically exchanged in limited environments, such as connectathons or pilots.
Criterion #4
Use Case(s) - Breadth of Applicability		 Level 0 - Use cases apply to a limited number of care settings or specialties, or data element represents a specialization of other, more general data elements.

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